ISSUE:                       Compliance Policy Guide for “The Public Health Security and Bioterrorism Preparedness and Response Act of 2002” (BTA)

 

BACKGROUND:            The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act/BTA) was signed by President Bush on June 12, 2002.  The purpose of the Act is “To improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies”.

 

CURRENT STATUS:           The Food and Drug Administration (FDA) has published a Compliance Policy Guide as direction for FDA and Customs and Border Protection (CBP) staff related to the Prior Notice provision of the BTA.  Under our joint discretionary enforcement authority, it sets forth a policy of informed compliance that will be phased in over the next eight (8) months.  It identifies four (4) different phases as we move from informed compliace to full enforced compliance.

 

Phase 1: December 12, 2003 – March 12, 2004

 

No shipments will be stopped for admisitrative failure.  Only the National Targeting Center (NTC) will be able to place a hold on any shipment subject to the BTA and that would only be for a perceived threat.  All other shipments will be processed under informed compliance with educational materials eg, flyers and pamphlets, and outreach, letters and meetings with the trade.

 

Phase 2: March 13, 2004 – May 12, 2004

 

No shipments stopped for administrative failure.  Penalties against repetitive egregious violators who have been counseled, begin.

 

Phase 3: May 13, 2004 – August 12, 2004

 

ABI System turned on. Failure to provide Prior Notice will result in refusal of the shipment and/or penalty.  Refusal results in merchandise being held at port of arrival, sent to a secure facility as determined by the CBP port director or exported under CBP supervision.

 

Phase 4: August 13, 2004 and thereafter

 

Full enforcement.  Failure to provide Prior Notice will result in refusal of shipment and/or penalty.  FDA determination that Prior Notice data is either incomplete or inadequate will also result in refusal of merchandise.

 

Specific operational details are being prepared now by the various impacted offices, such as, the Office of Information and Technology (OIT), the National Targeting Center (NTC) and the Office of Field Operations (OFO).  This coordination and cooperation will lead to a successful implementation of the full enforcement phase.

 

RECOMMENDATION:            For your information.

 

 

PREPARED BY:                Cathy Sauceda

                                                Office of Field Operations

                                                Bureau of Customs and Border Protection

                                                December 11, 2003